Inverting temporary valve sheath

ABSTRACT

A percutaneous device including a temporary valve attached to a sheath, the sheath having an inverting section for delivery and removal thereof from a blood vessel. The sheath is inverted for delivery, housing the valve between inverted layers thereof. To deploy said valve, the sheath is everted to position the temporary valve on an outer surface thereof. The temporary valve and sheath are reversibly movable between inverted and deployed configurations. Upon eversion, the temporary valve assumes a radially expanded canopy shape having an outer diameter selected to contact the vessel wall and allow blood flow in only one direction. The temporary valve may be removed by releasing one end of the valve from the sheath, flattening the temporary valve along the longitudinal axis of the sheath. Also provided is a temporary valve system comprising a dilator for inverting and everting the sheath, said dilator being removably connected to the sheath.

This application is a divisional of U.S. patent application Ser. No.15/593,484 filed May 12, 2017 and claims the benefit of priority of U.S.Provisional Application Ser. No. 62/336,983 filed May 16, 2016, all ofwhich are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to a temporary valve and sheath formaintaining normal blood flow during percutaneous cardiovascularprocedures. The invention also relates to a system comprising aninverting temporary valve device, a method of deploying said device in aliving body and a method of removing said device from the body.

BACKGROUND OF THE INVENTION

Valves are important structures in the human heart because they maintainblood flow in a single direction with minimal pressure loss. However,human heart valves can degenerate for a variety of reasons. For example,a malfunctioning heart valve may be stenotic, where the leaflets of thevalve do not open fully, or the valve may be regurgitant, where theleaflets of the valve do not close properly, or a combination of both.Valve repair and replacement procedures have thus been developed toeither restore the function of the native valves or to implant apermanent prosthetic valve with or without removal of the originalnative valve. The standard surgical procedure involves the opening ofthe patient's thoracic cavity, which is highly invasive and requirescardiopulmonary bypass and a prolonged recovery time.

Percutaneous valve repair and replacement procedures have been developedas cheaper and safer substitutes for traditional open chest surgeries.Compared to traditional surgery, a percutaneous valve repair procedureis minimally invasive and eliminates the need for cardiopulmonarybypass. In the absence of cardiopulmonary bypass, the percutaneousprocedure must take place quickly to restore normal circulation, becausenative valve function is interrupted during the repair or thepositioning and implantation of the permanent prosthetic valve. Atemporary valve is a useful tool to, in one respect, maintainunidirectional blood flow during the percutaneous procedure before thepermanent prosthetic valve is implanted and/or operational. Further, atemporary valve may be useful during a balloon aortic valvuloplasty(BAV) procedure in which the native valve is dilated with a balloon andwhich occasionally causes harm to one or more of the native valveleaflets. The temporary valve may serve to replace the function of theone or more native valve leaflets damaged during the BAV procedure. BAVprocedures may be stand-alone (e.g., in which no prosthesis isimplanted) or may precede percutaneous prosthetic valve implantationseither immediately or by a period of several hours, days or weeks.

Therefore, a need exists for a device that can maintain blood flow in asingle direction during, e.g., a percutaneous valve repair orreplacement procedure and may be removed without causing trauma to thevessel or unduly increasing the time or effort needed to complete theprocedure.

SUMMARY OF THE INVENTION

The invention relates to a device comprising a percutaneous temporaryvalve and sheath having an inverting section for delivery and removal ofthe percutaneous temporary valve from a target blood vessel. Theinvention also relates to a percutaneous temporary valve system andmethod of deployment. The device may be used in percutaneous valverepair procedures, valve replacement procedure or any situation in whichnative valve function is insufficient. The device may be removed withoutcausing trauma to the vessel or unduly increasing the time or effortneeded to complete the procedure. The device may provide temporaryhemodynamic support to a patient for various periods of time lastingfrom seconds to hours and possibly days.

The invention provides a temporary percutaneous valve device, comprisinga sheath having a first section located distally of a second section,said first section having a temporary valve attached thereto. In oneembodiment, the first section may be formed of a plurality of braidedmembers (e.g., fibers, wires, etc.). The first section is inverted fordelivery, housing the valve between inverted layers thereof. In theinverted configuration, at least a portion of the first section isturned or folded into itself, with the valve situated between layers ofthe first section, such that all or part of the first section extendsinto a luminal portion of the second section. To deploy said temporaryvalve at a target site, the first section is everted to position thetemporary valve on an outer surface thereof. The temporary valve andfirst section are reversibly movable between said inverted configurationand a deployed configuration, wherein, during deployment, said firstsection is moved distally out of said sheath channel. Upon eversion, thetemporary valve assumes a radially expanded canopy shape having an outerdiameter selected to contact the vessel wall and allow blood flow inonly one direction, e.g., away from the heart, for example duringsystole. The temporary valve may be held in its canopy shape by aplurality of lines connecting the outer diameter of the valve to thefirst section. Alternatively, the plurality of lines may connect theouter diameter of the valve to the second section.

The invention also relates to a temporary percutaneous valve systemcomprising a dilator used for inverting and everting the sheath. Thedilator is received through said sheath and includes first and secondwires coupling the dilator to the sheath such that proximal movement ofthe dilator relative to the sheath causes the first section to beinverted and distal movement of the dilator relative to the sheathcauses the first section to be everted. The connection between thedilator and sheath is removable, thus allowing the dilator to bewithdrawn from the system upon deployment of the temporary valve.

The invention also relates to a method for removing the deployedtemporary valve from a vessel. In one embodiment, the lines of thetemporary valve may be disconnected from the sheath, said disconnectionpermitting the canopy of the temporary valve to move to a substantiallytubular configuration, e.g., by everting. Once disconnected, the valvedevice, including the sheath and temporary valve may be withdrawn fromthe body. In another embodiment, the temporary valve and sheath may bewithdrawn from the body without inverting. In yet another embodiment,the temporary valve may be inverted into the sheath for withdrawal fromthe body. In this embodiment, the inversion may be carried out via athird wire which extends through a lumen of the dilator and out of adistal end of the dilator to loop about a portion of the first sectionof the sheath containing the temporary valve, connecting the temporaryvalve and sheath to the third wire. A proximal end of the third wireremains outside of the dilator and is accessible by a surgeon. Duringremoval, the surgeon pulls the third wire proximally to invert the firstsection proximally into the second section. The inverted sheath andvalve have a reduced outer profile and can be removed from the vessel.

The system and method disclosed herein is adapted for use in surgicalmethods including, but not limited to, open surgical procedures,percutaneous procedures, minimally-invasive procedures, trans-catheterprocedures, direct-entry procedures, endoscopic procedures, and thelike, as those skilled in the art will understand. Although the systemsand methods disclosed herein are described with respect to apercutaneous procedure, any other approach may be used without deviatingfrom the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a sheath and temporary valve according to a firstembodiment of the invention in a radially expanded canopy configuration.

FIG. 2 illustrates the sheath and temporary valve of FIG. 1 during adetached configuration.

FIG. 3 illustrates the sheath and temporary valve of FIG. 1 in aneverted configuration.

FIG. 4 illustrates a partial cross-sectional view of the sheath andtemporary valve of FIG. 1 in a deployed configuration.

FIG. 5 illustrates a partial cross-sectional view of the sheath andtemporary valve of FIG. 1 in an inverted insertion configuration.

FIG. 6 illustrates a system for delivering and deploying the sheath andtemporary valve of FIG. 1.

FIG. 7 illustrates the system of FIG. 6 in a deployed configuration.

FIG. 8 illustrates a zoomed view of the system of FIG. 7.

FIG. 9 illustrates a partial cross-sectional view of a sheath andtemporary valve according to a first alternate embodiment in a deployedconfiguration.

FIG. 10 illustrates a sheath and temporary valve according to a secondalternate embodiment in a radially expanded canopy configuration.

FIG. 11 illustrates the sheath and temporary valve of FIG. 10 during adetached configuration.

FIG. 12 illustrates the sheath and temporary valve of FIG. 10 during aneverted configuration.

DETAILED DESCRIPTION OF THE INVENTION

The invention relates to an inverting sheath and an integratedpercutaneous temporary valve for use in intraluminal procedures. Theinvention also describes a method of delivery and deployment of apercutaneous temporary valve system and methods for its removal.

Device

A device according to the invention comprises a sheath having a firstsection located distally of a second section, said first section havinga temporary valve attached thereto. In an embodiment of the invention, afirst end of the temporary valve is permanently attached to the firstsection and a second end of the temporary valve is removably attached tothe first section by a plurality of lines. In one embodiment, the firstsection and temporary valve are movable between an inverted or partiallyinverted configuration for delivery and a radially expanded canopy orumbrella configuration after deployment. Expansion of the canopy fromthe inverted configuration may be aided by optional ribs in the valvebody. A package or kit according to the invention further comprises acatheter or other similar known intraluminal delivery instrument.

The device may be used with a dilator insertable through the sheath. Thedilator, which aids in intravascular access, delivery and deployment,also controls inversion and expansion of the temporary valve. Thedilator is removably coupled to the temporary valve and sheath via firstand second wires. As the dilator slides proximally and distally throughthe sheath, a connection of the first and second wires to the temporaryvalve and first section causes a corresponding inversion and/or eversionof the first section. Specifically, the first wire extends through alumen of the dilator and out of a distal end of the dilator to loopabout a portion of the first section of the sheath containing thetemporary valve, connecting the temporary valve and sheath to thedilator. A proximal end of the first wire remains outside of the dilatorand is accessible to a surgeon.

Delivery and Deployment

The sheath is inverted prior to delivery to house the valve betweeninverted layers of the sheath in the inverted configuration within theguide tube. To deploy said temporary valve at a target site, the firstsection is everted to permit a radial expansion of the temporary valveand position the temporary valve on an outer surface thereof. Upondeployment, the temporary valve assumes a radially expanded canopy shapehaving an outer diameter and allows blood flow in only one direction,i.e., during systole. As used herein, the term deliver refers to adelivery of the sheath or other device components from outside the bodyto a selected intravascular location. The term deployment, as usedherein, refers to a configuration in which the dilator is pusheddistally, expelling and everting the first section of the sheath andcausing an expansion (i.e., deployment) of the temporary valve. In oneembodiment, radial expansion of the canopy from the invertedconfiguration may be aided by optional ribs in the valve body, said ribshaving a structural rigidity to automatically assume a canopyconfiguration independent of blood flow through the vessel. Thetemporary valve is held in the canopy shape by optional lines, which mayconnect at one end to attachment points on the first section of thesheath and at the other end to the perimeter of the valve canopy. Asblood flows through the vessel in a first direction during systole, theblood applies a pressure to an outer surface of the canopy, causingradial compression thereof and allowing flow therepast. As blood flowsin an opposite second direction during diastole, the blood appliespressure to an inner surface of the canopy, causing radial expansionthereof to effectively impede blood flow through the vessel. Thus, inthe canopy configuration, the temporary valve allows blood flow in onlyone direction, i.e. during systole. A permissible volume of blood maymove past the temporary valve during diastole, e.g., between an outerperimeter of the canopy and the vessel wall and/or through a lumen ofthe temporary valve. However, the volume of this blood flow is small andstill permits maintenance of unidirectional blood flow through thevessel. The valve device thus permits continued functionallyunidirectional blood flow through a target vessel during a targetprocedure, even in the absence of a native valve and/or the presence ofa non-functional or partially functional native valve.

Inversion and radial expansion of the temporary valve and sheath duringdelivery and deployment is controlled by movement of the dilator withinthe sheath; that is, resulting in an inversion of the temporary valveand sheath when proximal movement of the dilator occurs and resulting ineversion and radial expansion of the temporary valve when distalmovement occurs. The term proximal, as used herein, refers to adirection toward a hub of the sheath (i.e., in the direction of bloodflow during systole and the term distal refers to a direction oppositethe proximal direction (i.e., toward the target treatment site)). Oncethe temporary valve has been deployed at a target position in thevessel, the first wire is pulled out of the device, disconnecting thedilator from the sheath and permitting withdrawal of the dilatorproximally of the sheath while the temporary valve and sheath remain inthe vessel.

Removal from the Body

The temporary valve of the invention may be used to control the heart'sblood flow during various surgical procedures requiring suchintervention. For example, a temporary valve may be needed before,during or after surgical procedures (e.g., during preparation for asurgical procedure) such as a valve replacement, valve repair or otherheart surgeries. Once the procedure is completed, the valve and sheathmay be removed from the body in one of a number of ways. In oneembodiment, a portion of the temporary valve may be detached from thefirst section of the sheath by releasing the lines to reduce an outerprofile of the valve, the detachment permitting the canopy of the valveto move to an elongated, substantially straightened tubularconfiguration (an everted position) or any shape permitting easierremoval from the body. Specifically, only a portion of the temporaryvalve is detached from the sheath in the detached configuration. A firstend of the temporary valve remains permanently attached to the sheathwhile a second, opposite end is reversibly connected to said sheath. Thepermanently attached first end of the temporary valve forms a continuoussheet or canopy of the temporary valve. This detachment of the secondend may also serve to reduce friction encountered during the procedureand/or change the shape of the temporary valve, as described in greaterdetail with respect to FIGS. 1-8 below. Specifically, an attachment wireconnecting the lines to the first section of the sheath may be withdrawnproximally, thereby releasing a connection between the lines and firstsection. This release allows the valve body to assume a reduced outerprofile by, for example, straightening, everting or otherwise shiftingposition or shape. Once detached, the device, including the firstsection and temporary valve may be withdrawn from the body. In anotherembodiment, the temporary valve and sheath may be withdrawn from thebody without everting. Specifically, the flexible materials of thetemporary valve allow for removal thereof from the body without causingundue trauma to the vessel. In yet another embodiment, the temporaryvalve may be inverted for withdrawal from the body, said inversion beingcarried out via a third wire and being independent of the position ofthe dilator within the sheath. The third wire extends through a lumen ofthe dilator and out of a distal end of the dilator to loop about aportion of the first section containing the temporary valve, connectingthe temporary valve and first section to the third wire. The proximalend of the third wire remains outside of the dilator and is accessibleby a surgeon. During removal, the surgeon pulls the third wireproximally to move the first section of the sheath proximally. Thesecond section remains stationary such that the proximal movement of thefirst section causes inversion of the first section and temporary valveinto the second section. The inverted first section and valve have areduced outer profile and can be removed from the vessel.

FIGS. 1-8 illustrate a percutaneous temporary valve device according tothe invention. One embodiment of the invention, shown in FIG. 1illustrates temporary valve device 100 which comprises a delivery device102 and a temporary valve body 104. The delivery device 102 includes asheath 101 having a first section 103, second section 105 and optionalouter tube 107. The temporary valve body 104 is movable between thedeployed radially expanded canopy shaped configuration of FIG. 1 and aninverted insertion configuration, as depicted in FIG. 5. The temporaryvalve body 104 has an elongated tubular valve canopy 106 extending froma first end 108 to a second end 110. A lumen 112 extends through thetemporary valve body 104, the lumen being sized to receive the sheathfirst section 103 therethrough, the first section 103 further beingsized to slidably receive a catheter shaft (not shown) therethrough. Inone embodiment, the temporary valve device may have a pre-deploymentlength of 54 cm and a post-deployment length of 62 cm.

As depicted in FIG. 1, an outer perimeter of the tubular valve canopy106 forms an umbrella or parachute shape. A diameter of the valve canopy106 at region A is uniform or substantially uniform and closely matchesan outer diameter of the first section 103. The temporary valve 104further comprises a region B forming an outer perimeter of the canopy.As depicted in FIG. 1, region B represents a radially expanded canopyconfiguration of the valve canopy 106 and may have a length ofapproximately 25 mm. Region B′, as depicted in the example of FIG. 3,representing a straightened or everted configuration of the valve canopymay have a length of 45-50 mm. Alternatively, the region B′ may have alength in the range of 10-100 mm. The outer perimeter of the canopyabuts the vessel wall whereas the first end 108 of the valve body 104 issecured to the first section 103. Dimensions of the valve canopy 106 areselected so that a maximum outer diameter D of the valve canopy 106 inthe deployed umbrella-shaped configuration is selected to closely matcha diameter of a vessel within which the valve device 100 is implanted.For example, the maximum outer diameter of the deployed valve canopy 106may be 20-30 mm or 35 mm although larger and smaller diameters areenvisioned to permit use of the device 100 in larger or smaller vessels,respectively. Preferably, the maximum outer diameter of the deployedvalve canopy 106 substantially matches or is slightly larger than adiameter of a vessel in which the valve body 104 is to be implanted. Forexample, a maximum outer diameter of the deployed valve canopy 106 maybe 6-10 mm, or 8 mm when used in a femoral artery and approximately14-30 mm, 18 mm, 20-30 mm or 45 mm when used in a proximal descendingaorta. In a preferred embodiment, an unconstrained diameter of the valvecanopy may be 45 mm or anywhere in the range of 10-80 mm. Theunconstrained diameter of the valve canopy 106 may be selected to matchthe diameter of the vessel in which the valve canopy 106 is inserted ormay be larger than the diameter of said vessel. For example, the vesseldiameter to valve canopy diameter ratio may be from 1:1 to 1:5. In oneembodiment, the ratio is 1:2. The above dimensions are exemplary onlyand any other diameter appropriate for a particular vessel may beemployed herein without deviating from the scope of the invention.

In one embodiment, a plurality of ribs 114 may be provided and evenlydistributed about a circumference of the valve canopy 106, the ribsextending from first ends 116 to second ends 118. The ribs 114structurally reinforce the valve canopy 106 and define a shape thereof.That is, in the deployed position illustrated e.g. in FIG. 1, the ribs114 maintain the valve canopy structure to hold an open umbrella-shapedposition, even in the absence of blood flow. The ribs 114 may beattached to an inner or outer surface of the valve canopy 106. Inanother embodiment, the ribs 114 may be embedded in the material of thevalve canopy 106. In a preferred embodiment, the device 100 includespreferably 4-12 ribs, more preferably eight ribs 114, although a greateror lesser number of ribs 114 may be used without deviating from thescope of the invention. The number of ribs may range from 2-20 or 6-15.In another embodiment, the device may include sixteen ribs. The numberof ribs is selected to provide a balance of structural rigidity whilestill permitting the valve canopy 106 to fold and unfold easily. Theribs are preferably evenly spaced about the circumference of the canopy.The first ends 116 of the ribs are axially separated from the first end108 of the valve canopy 106 by a predetermined distance around thecircumference of the first section, denoted by region A of FIG. 1. Theribs extend from an end of the region A to the second end of the valvebody 110. Region A comprises a glue or polymer as known in the art tosecure the first end 108 of the valve body (and optionally the ribs 114)to the first section 103. Alternatively, the region A may be omitted andthe proximal end of the region B may be secured directly to the firstsection 103. As depicted in FIG. 1, during systole, blood flows in thedirection 1 and applies a pressure to an outer surface 117 of thetemporary valve, causing the valve canopy 106 to partially compress andallow blood flow therepast. During diastole, blood flows in thedirection 2 and applies a pressure to the inner surface 119 of thetemporary valve body 104, thereby preventing blood from flowing past thecanopy 106 due to engagement with the inner surface of the valve canopy106.

The second end 118 of each of the ribs 114 may optionally include a ring120 permitting attachment of lines 130 thereto. The lines 130 secure theribs 114 or, in an embodiment where the ribs 114 are omitted, an edge ofthe valve body 104 to the first section 103 at a position proximal tothe valve canopy 106. This attachment position is exemplary only andother attachment positions may be used without deviating from the scopeof the invention. For example, lines 130 may be connected to the valvebody 104 or distal thereto or to the second section 105. The rings 120are formed as a loop of the same material as the ribs 114, althoughother materials are also envisioned. The rings 120 may be unitary withthe ribs 114 or, in another embodiment, may be separate elementsattached thereto via welding or another attachment means known in theart. In yet another embodiment, the lines 130 may be attached to theribs 114 by an attachment mechanism other than rings (e.g., gluing,welding, etc.). The second ends 118 of the ribs may be separated fromthe second end 110 of the valve canopy 106 by a gap. The length of thegap may be selected to prevent free or sharp edges of the ribs 114 fromcoming into contact with luminal tissue. The length of the valve canopy106 in the gap may be scrunched or gathered when a line 130 is attachedto the ring 120. In another embodiment (not shown), the second end ofthe ribs 114 may extend to a distal edge of the valve canopy 106 withoutthe gap. In yet another embodiment, the ribs may extend beyond thesecond end of the valve body, wherein the second end of the ribsconnects directly to the first section without the use of lines 130.

In another embodiment (not shown), the device 100 may be formed withoutribs 114. In this embodiment, the valve canopy 106 may include one ormore radiopaque markers disposed on, under or embedded therein. Further,lines 130 may be secured directly to the valve canopy material (e.g.,knotted to openings formed through the valve canopy, formed integrallywith the valve canopy 106, formed as extensions of the valve bodymaterial, etc.).

The plurality of lines 130 connect the temporary valve body 104 to thefirst section 103. Each of the plurality of lines 130 is knotted orotherwise secured to the valve canopy at a second end and secured to thefirst section 103 at a first end to an attachment area located proximalof the first end 108 of the temporary valve body 104. As noted earlier,the plurality of lines are not necessarily located proximal of the valvebody 104 and may be located on the valve body 104 or distal thereto.Each of the lines 130 may include a loop, hook or other attachmentelement at a free end to permit weaving or other reversible connectionto an attachment wire 140. Loops 134 may extend for a portion of or theentire length of the lines 130. Each of the lines 130 may haveapproximately the same length or alternatively, the lines 130 may have acombination of long and short lengths, said length(s) being selected tomaintain the valve canopy shape when deployed in the vessel wall. Freeends 136 of lines 130 are positioned circumferentially about the firstsection 103 at the attachment point 132 and connected thereto via theattachment wire 140. The attachment wire 140 extends through deliverydevice 102 from the proximal opening toward the attachment area 132 andis sequentially interwoven with each of the loops, hooks or otherattachment elements and an adjacent opening of the first section 103 tosecure the loops to the first section 103. As such, the attachment wiresecures the lines 130 at the attachment point in a manner to form areversible attachment between the valve and sheath 101. In analternative embodiment, the attachment wire 140 may be replaced by astring, removable pin or other attachment mechanism.

During manufacture of the device, the attachment wire 140 is passedthrough the braiding of the first section 103 at attachment point 132 a,is sequentially woven through respective loops, hooks or otherattachment elements and openings in the first section about said firstsection circumference and subsequently extends outside the first section103 at attachment point 132 b. In another embodiment, the attachmentwire 140 extends inside the first section 103 at attachment point 132 b,the attachment wire 140 being housed within the first section 103. Inone embodiment the attachment wire 140 extends 180 degrees about thefirst section 103 at the attachment point 132 b. In other configurationsthe attachment wire is woven about all of some portion of thecircumference of the first section, e.g., 90 degrees, 180 degrees, 270degrees or e.g. 360 degrees. The first free end of the attachment wire140 is then woven back into the lumen of the delivery device 102 and outof the proximal end thereof (not shown) so that both first and secondfree ends of the attachment wire 140 are located at the proximal end ofthe delivery device, accessible to the operator.

Once use of the temporary valve is completed, the invention furthercomprises a method of removing the temporary valve comprising, in oneembodiment, releasing one of the first and second free ends of theattachment wire 140 and retracting the attachment wire 140 from thebody, thereby releasing the lines 130 from the attachment wire. Thisrelease, or detachment, permits the valve canopy to be opened andstraightened to a reduced outer circumference, as shown in the evertedconfiguration of FIG. 3, thereby facilitating removal thereof from thebody while minimizing or preventing trauma to the vessel wall. The valvebody and the optional ribs straighten, becoming aligned along the lengthof the first section (as shown in FIG. 2 and FIG. 3). The first section103 may be secured at its proximal end 150 to the distal end 152 of thesecond section 105 via an attachment means known in the art such ase.g., thermal bonding, glue, or the like. The first section 103 andsecond section 105 may be connected to one another by a means known inthe art, such as for example a contiguous configuration. In analternative embodiment, the first and second sections 103, 105 mayoverlap at their junction. A distal end 154 of the first section 103 ofthe sheath 101 may optionally be sealed using a cuff or other sealant toprevent the free ends of the braid from unwinding, as one of skill inthe art will understand. Alternatively, the distal end 154 may be sealedagainst unwinding by one or more of gluing to a polymer, sewing, moldingor another sealing option known in the art. In an alternate embodiment,the first section 103 may be manufactured via a closed braid techniquewherein the braid does not include sharp free ends at a distal end andis not prone to unwinding, as those of skill in the art will understand.

As depicted in the partial cross-sectional view in FIG. 4, the secondsection 105 has a diameter slightly larger than a diameter of the firstsection 103 to permit slidable movement of the first section 103therethrough. A proximal end of the second section 105 includes ahemostatic valve 156 which prevents blood backsplash, as those of skillin the art understand. The second section 105 has an internal diameterof 6-24 French and an outer diameter of 8-30 French. In one embodiment,the internal diameter of the second section 105 is 12 French and theouter diameter is 14 French or approximately 5 mm. These values areexemplary only and may be modified to conform to the dimensions of atarget vessel through which the device 100 is to be inserted and/or thedimensions of a treatment device that needs to pass through the device100.

The first section 103 may be formed with any diameter sufficiently largeto permit a replacement valve, balloon or other device to be insertedtherethrough. In one embodiment where the device is being delivered viaa catheter having a diameter of 5 mm, the first section 103 may alsohave a diameter of 5 mm. In a preferred embodiment, the first section103 diameter may range from 2-9 mm, although smaller or largerdimensions may be used without deviating from the scope of the inventionto address the requirements of a particular procedure and/or treatmentlocation, as those of skill in the art will understand. The firstsection 103 may have a length in the range of 2-20 cm and preferably 10cm. In a preferred embodiment, the temporary valve 104 is positioned 2.5cm from the distal end 154 of the first section 103, although any otherplacement along the first section 103 is envisioned within the scope ofthe invention. In one alternate embodiment, the temporary valve 104 ispositioned at the distal end 154.

The delivery device 102 further comprises a dilator 160 extending from aproximal end 162 located outside the body to a distal end 164 having atip formed as a nosecone 166. The dilator 160 comprises a tubular body,a distal nosecone and a waist therebetween, wherein said dilator aids indilation of the vessel to facilitate insertion of the device 100 intothe body at a target site. The tubular body of the dilator 160 matchesor is smaller than an inner diameter of the first section 103 to permitthe dilator 160 to be received therethrough. The nosecone 166 maygradually reduce in diameter toward the distal end 164 and may have aconical outer profile. The taper of said nosecone 166 may be linear orexponential. Alternatively, the nosecone may be blunt-ended having noconical or tapered shape but rather be flat-topped, spherical or othershapes. The nosecone 166 is separated from the body 168 of the dilatorby a waist 170 which is permanently attached to the tubular body 168 andnosecone 166. The waist 170 has a reduced diameter relative to thenosecone 166 and is configured to form a negative space therearound inwhich the valve canopy 106 of the valve body 104 is housed in itsinverted delivery configuration. Further, although the embodiment ofFIGS. 4-5 and 7-9 shows waist 170 having a diameter smaller than thetubular body 168, other configurations are envisioned within the scopeof the invention. For example, the tubular body 168 may alternatively beformed with a diameter less than or equal to the waist diameter. Thewaist 170 may be formed of a rigid, semi-rigid or flexible material. Inone embodiment, a diameter of the nosecone 166 may be tapered in thedistal direction, as depicted in FIG. 6. In another embodiment, thetransition between the nosecone 166 and the waist 170 may not betapered, as depicted in FIG. 4. The diameter of the dilator body 168 mayalso be tapered toward the waist 170. In yet another embodiment (notshown), an additional element—e.g., a non-tapered segment—may beprovided between the nosecone 166 and the waist 170.

In one embodiment, the nosecone 166 includes openings 172 adapted toreceive first wires 182. The first wire 182 includes loops 184 at itsrespective free ends. The loops 184 may have any length relative to thelength of the first wire 182 and are not limited to the dimensionsdepicted in FIG. 4. The first wire 182 may connect one or more openingsin the nosecone to a second wire 186. The length of the first wire 182may be approximately the length of the waist or twice the length of thewaist, although any other length may be used without deviating from thescope of the invention. The first wire 182 comprises a biocompatiblematerial, e.g. Nitinol, polymer or other like biocompatible material.The above embodiment is exemplary only. The first and second wires 182,186 may be attached to the nosecone 166 in other ways without deviatingfrom the scope of the invention.

The dilator body 168 also includes a distal opening 176 to receive asecond wire 186 therethrough (see FIG. 4, e.g.). The second wire 186 maycomprise Nitinol wire or polymer having free ends 188 located outside ofthe body and inserted into the dilator from a proximal end thereof. Asshown in FIGS. 4 and 6, a proximal end of the dilator 160 may be fittedwith a hub 180 through which the second wire 186 traverses. One end ofthe second wire 186 is located at the proximal opening 185 at the hub180 of the dilator 160. The dilator 160 is hollow and includes a centrallumen 187 extending therethrough from said proximal opening 185 to saiddistal opening 176. In one embodiment, the hub may include a lockingmechanism (e.g., a knob) to temporarily lock the second wire 186 againstmovement,—e.g., to prevent unwanted movement of the second wire. Thelocking mechanism (e.g., the knob) may be unlocked to permit movement ofthe second wire 186. The second wire 186 traverses the length of thecentral lumen of the dilator and extends out of the distal opening 176of the dilator and is sequentially woven through the loops 184 of thefirst wire 182 to secure the first and second wires to one another. Thesecond wire 186 then extends proximally into the first section 103toward sheath attachment location 190, between an outer surface of thedilator 160 and an inner surface of said first section 103. The secondwire 186 then extends in and out of the first section 103 any pluralityof times at the sheath attachment location 190, thereby securing thefirst section 103 to the dilator 160. Specifically, the second wire 186exits the first section 103 at attachment point 190 a, extends 180degrees about said first section 103 and subsequently extends into theluminal side of the first section 103 at attachment point 190 b. Thesecond wire 186 then completes a symmetric circuit, extending throughthe first section 103, into the second one of the loops 184, back intothe distal opening 176, through the channel 187 extending out theproximal opening 185 of the dilator. It is noted that although thesecond wire 186 is described as extending 180 degrees about the firstsection 103, other configurations may be employed without deviating fromthe scope of the invention, including approximately 180 degrees, lessthan 180 degrees or more than 180 degrees.

When the dilator is manually advanced distally in direction 2, the valvebody 104 is also advanced distally. Specifically, as the nosecone 166 isadvanced in a distal direction, the first and second wires 182 and 186,which couple the dilator to the valve body 104, also move distally. Thisdistal movement facilitates movement of the device from its inverteddelivery configuration to a deployed configuration. The dilator 160 maybe used to move the valve and first section 103 between the invertedinsertion configuration and deployed configuration any plurality oftimes as needed to perform a procedure.

The method described above is one example of how the dilator 160 maydeploy the first section 103 and temporary valve 104. Other deploymentmethods are within the scope of the invention. In one non-limitingexample, the distal end of the dilator body 168 may be used to push thetemporary valve 104 out of the first section 103.

The invention further comprises an inverted delivery configuration ofthe temporary valve system. In an exemplary embodiment, the device 100is first positioned to an inverted delivery configuration from theradially expanded canopy configuration shown in FIG. 1, an embodiment ofwhich is shown in the partial cross-sectional configuration of FIG. 5.In the inverted delivery configuration, the dilator 160 is retractedproximally in direction 1, i.e., proximally. The dilator 160 isconnected to the first section 103 and valve body 104 via the first andsecond wires 182, 184. Thus, proximal movement of the dilator causes acorresponding proximal movement of the first section 103 and valve body104. As the dilator 160 is positioned proximally, the first section 103first becomes compressed, and then inverts, or flips outside in, asshown in FIG. 5. In one embodiment, an overall length of the firstsection 103 in the inverted delivery configuration is one-half of thelength of the first section 103 in the deployed configuration, althoughother dimensions may be possible depending on the distance the dilatoris retracted. In the inverted delivery configuration, the valve body 104is positioned between two layers of the first section, as shown in FIG.5. The inverted first section 103 and valve body 104 are housed withinthe second section 105 in the negative space formed around the waist170. In the inverted delivery configuration, the nosecone 166 ispositioned near the distal end of the second section 105 to facilitatepushable entry thereof into the body and through the vessel, as thoseskilled in the art will understand. Optionally, the nosecone may befully retracted into the second section 105.

The invention further comprises a method of delivering and deploying thetemporary valve. The sheath 101 is advanced through the body to a targetlocation in the inverted delivery configuration. Once at the targetlocation, the dilator 160 is advanced distally in the direction 2, saiddistal movement being transferred to the first section 103 via the firstand second wires 182, 184. As the dilator moves distal from the secondsection 105, the first section 103 everts to an elongated, non-foldedconfiguration, as shown in FIGS. 7-8. As the valve body 104 exits thesecond section 105, the canopy 106 of the valve body 104 radiallyexpands outward to an umbrella configuration. In embodiments withoutribs 114, the radial expansion may be caused by the flow of bloodtherepast during diastole. In one embodiment, once the valve body 104has been properly positioned in a target location, one free end 188 ofthe second wire 186 may be retracted in the direction 1 to remove thesecond wire 186 from the device 100 and out of the body. This retractionreleases the second wire 186 from the first wire 182 and attachmentlocation 190, thereby disconnecting the first section 103 from thedilator 160. The dilator 160 may then be removed from the device andfrom the body without affecting the position of the first section 103and valve body 104. A catheter (e.g., balloon catheter, TAVI catheter,etc.) may then be inserted into the sheath 101 via the hemostatic valve156 to perform a target procedure. Once the target procedure iscompleted, the valve body 104 and first section 103 must be removed fromthe body. Removal of the device 100 may be performed in a number ofways, each of which is described separately hereinafter. It is notedthat the proximal retraction of the dilator 160 and the second wire 186may be performed in any order depending on clinical convenience.

In a first method of removing the temporary valve, the device 100 isremoved from the body with the valve body 104 in the umbrella orradially expanded canopy configuration. This method is especiallyexpedient in an embodiment without ribs 114 as it reduces the additionaltime needed to perform a procedure. However, even in the embodimentincluding the ribs 114, the expanded valve body 104, due to its flexibleconstruction, may be removed with a negligible amount of trauma to thepatient vessel. In this embodiment, the lines 130 may be permanentlyfixed to attachment points 132 and no attachment wire 140 is needed.

In a second method of removing the temporary valve, the lines 130 of thevalve body 104 are separated from the first section 103 to permit thevalve body 104 to straighten for removal. Once a valve repair orreplacement procedure is completed, one free end of the attachment wire140 is pulled proximally, causing the second free end to be pulledthrough the device 100 and to release loops 134 of the lines 130, asshown sequentially in FIGS. 1-3. Once the lines 130 disengage from firstsection 103, proximal retraction of the device 100 causes the now freeend 110 of the valve to move distally of the valve first end 108, asdepicted in FIG. 3. The valve body will evert and straighten becomingsubstantially aligned with the axis of the first section 103. Theoptional ribs 114 may be biased to a straightened or substantiallystraightened configuration to aid in movement of the valve to theconfiguration shown, e.g., in FIG. 3 upon release of the lines, therebyreducing the outer profile of the valve and permitting withdrawaltherefrom from the vessel without causing damage thereto.

In a third method of removing the temporary valve, as depicted in FIG.9, the valve body 104 may be moved back to a folded configuration intothe first section 103 for removal via an optional third wire 192.Specifically, the third wire 192 may be provided to control a reversibleinversion and eversion of the first section and valve independently ofthe position of the dilator. The third wire 192 may extend through thedilator channel 187 from the proximal opening 185 and exit therefrom viadistal opening 176 to connect directly to the first section in the samemanner as the second wire 186. Specifically, the third wire 192traverses the length of the central lumen of the dilator, extends out ofthe distal opening 176 of the dilator and moved proximally into thefirst section 103 toward the sheath attachment location 190, between anouter surface of the dilator 160 and an inner surface of said firstsection 103. The third wire 192 is then woven in and out of the firstsection 103 any plurality of times at the sheath attachment location190. Specifically, the third wire 192 exits the first section 103 atattachment point 194 a, extends 180 degrees about said sheath andsubsequently reenters the first section 103 at attachment point 194 b.The third wire 192 then completes a symmetric circuit, extendingdistally through the sheath, back into the distal opening 176, throughthe channel 187 and ends at the proximal opening 185 of the dilator.When the target procedure is completed, both free ends of the third wire192 are pulled proximally in the direction 1 to cause the first section103 to move proximally into the second section 105 and optionally becomeat least partially inverted within the second section. The invertedvalve body 104, having a lower outer profile than the radially expandedvalve, can then be removed from the body without damage or with minimalor negligible damage to a vessel wall. That is, in the straightenedeverted configuration of FIG. 3, the valve body 104 is more capable ofbeing radially compressed to permit retraction through narrowvasculature.

In some embodiments, the device 100 may include the protective outertube 107 extending over the second section 105 of the sheath 101, asdepicted in FIGS. 1-3. The outer tube 107 may be provided to secure anoptional wire tube 109 through which the attachment wire 140 may bereceived. The wire tube 109 may extend parallel to the second section105 but may be located outside of the second section 105 and extendingfully or partially coextensively thereto. In one embodiment, the distalend 111 of the wire tube 109 may be located proximal to the distal end152 of second section 105 with the attachment wire 140 extending out ofsaid distal end 111 and entering the first section 103 at the attachmentpoint 132. This embodiment lends the advantage of maximizing an internaldiameter of the second section 105 available for catheter insertion. Inanother embodiment, the wire tube 109 may be located inside the guidetube 105, thus minimizing an outer profile of the device. In yet anotherembodiment, the attachment wire 140 may be inserted through a channelformed in the side wall of the second section 105. In yet anotherembodiment, the outer tube 107 may be omitted, in which case theattachment wire 140 may run through the lumen of the guide tube 105.

The first section 103 may be formed of Nitinol, polymer or other knownmaterials and has a braided construction formed of one or more braidedmembers (e.g., fibers, wires, etc.). In an alternative embodiment, thefirst section 103 may be made of a non-braided construction such as aflexible tube formed of e.g., fabric or polymer. The second section 105may be formed of a polymer or other suitable material. The valve canopy106 may be formed of a thin, flexible and fluid-impervious polymermaterial such as an elastomeric polymer or any other polymer exhibitingthese properties. In another embodiment, the valve canopy 106 may beformed of fabric, pericardium, a metallic sheet, or another flexible,fluid-impervious material. The ribs 114 may be formed at least partiallyof a radiopaque material to aid in visibility of the device during thepercutaneous procedure. The ribs 114 may be formed of a substantiallyflexible metal, Titanium, Nitinol, or other metal known in the art.Alternatively, the ribs may be formed of a polymer material such as forexample polyurethane. The material of the optional ribs is preferablystiffer than the material of the valve canopy. Lines 130 may be formedof suture material, fabric, metal or a polymer. In another embodiment,the lines 130 may be formed as a continuation of the ribs 114 and formedof the same material as said ribs 114. The attachment wire 140 may beformed of Nitinol, metal, string, fabric, a polymer or other suitablematerials. The guide tube 105 and wire tube may be formed of a polymeror other known material and has a length selected to provide access to,for example, the proximal descending aorta, under percutaneous accesswith a proximal end thereof remaining external to the body andaccessible to a cardiologist or other user.

FIGS. 10-12 depict a device 200 according to an alternate embodiment.First section 103′ of device 200 includes a ring 202 to which lines 130are attached, the ring 202 comprised of a plurality of loops 204permanently attached to first section 103′ at attachment point 132(e.g., see FIG. 10). In a preferred embodiment, the number of loops 204corresponds to the number of lines 130, although any number of loops 204may be provided without deviating from the scope of the invention.Whereas the attachment wire of FIGS. 1-5 is woven directly into thefirst section 103 to secure the lines 130 to the first section 103, theattachment wire 140 of FIGS. 10-12 is interwoven with ring 202 to securethe lines 130 to the first section. During a manufacturing or apre-surgical step, the free end of the attachment wire 140 issequentially woven through a first one of the loops 204 and a first oneof the lines 130 and then through a second one of the loops 204 and asecond one of the lines 130 and so on. This configuration prevents theattachment wire 140 from being caught on the first section 103 duringremoval thereof. The ring 202 may be formed of a single wire wound toform a number of loops or may be formed of a plurality of individualloops 204 secured to the first section 103. The ring 202 may be formedof wire, suture material, string or another suitable material.

It will be apparent to those of skill in the art that many variations,additions, modifications, and other applications may be made to what hasbeen particularly shown and described herein by way of embodiments,without departing from the spirit or scope of the invention. Forexample, one or more features of the various embodiments disclosedherein may be combined in any combination. It is therefore intended thatthe scope of the invention, as defined by the claims, includes allforeseeable variations, additions, modifications or applications.

1. A method of deployment of a temporary valve, comprising: guiding thetemporary valve to a target position in a vessel in an invertedconfiguration, said temporary valve comprising a sheath having a firstsection and a second section, said first section attached to a distalend of said second section, wherein said temporary valve is attached toand housed by an inner surface of said first section in the invertedconfiguration, said temporary valve extending from a first valve end toa second valve end; and advancing a dilator distally through saidsheath, said distal advancement moving said temporary valve from aninverted configuration to a radially expanded canopy configuration,wherein said temporary valve is oriented on an outer surface of saidfirst section in said radially expanded canopy configuration.
 2. Themethod of claim 1, further comprising: moving said temporary valvebetween said inverted configuration and radially expanded canopyconfiguration any plurality of times.
 3. The method of claim 1, furthercomprising: moving said temporary valve to said inverted configuration;and withdrawing said temporary valve from said vessel in said invertedconfiguration.
 4. The method of claim 1, further comprising: retractinga wire connecting said valve device to said first section to invert saidfirst section and temporary valve proximally into said second section.5. The method of any of claims 1-4, wherein said temporary valvecomprises a plurality of lines connecting said second valve end to saidfirst section, the method further comprising: disconnecting said linesfrom said first section to permit inversion of said temporary valve; andwithdrawing said temporary valve from said vessel.
 6. The method ofclaim 5, wherein said lines are connected to said first section via acontrol wire, said method comprising the step of retracting said controlwire proximally from said temporary valve to disconnect said lines fromsaid first section.
 7. A method of removing a temporary valve devicefrom a body vessel, said temporary valve device comprising a sheathhaving a first section and a second section, said first section attachedto a distal end of said second section, a temporary valve attached to anouter surface of said first section, said temporary valve having a firstvalve end and a second valve end and comprising a plurality of linesconnecting said second valve end to said first section, and anattachment wire, wherein said lines are attached to said first sectionvia said attachment wire, said method comprising the steps of:retracting said attachment wire connecting said lines to said firstsection, said retraction disengaging said temporary valve from saidfirst section to facilitate removal of said temporary valve; andretracting said temporary valve device from the body.
 8. A method ofremoving a temporary valve device from a body vessel, said temporaryvalve device comprising a sheath having a first section and a secondsection, said first section attached to a distal end of said secondsection; and a temporary valve attached to an outer surface of saidfirst section, said temporary valve having a first valve end and asecond valve end and comprising a plurality of lines connecting saidsecond valve end to said first section, said method comprising the stepof: retracting said temporary valve device from the body.
 9. A method ofremoving a temporary valve device from a body vessel, said temporaryvalve device comprising a sheath having a first section and a secondsection, said first section attached to a distal end of said secondsection, a temporary valve attached to an outer surface of said firstsection, said temporary valve comprising a plurality of lines connectingsaid second valve end to said first section, and a dilator positioned totraverse said sheath, said dilator having a wire extending therethroughand out of a distal opening in said dilator to couple said temporaryvalve to said first section, said method comprising the steps of:pulling said wire, thereby retracting a distal portion of said firstsection into a luminal portion of the second section to invert thetemporary valve; and retracting said temporary valve device from thebody.